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NCT Number: NCT04778891

The Impact of Comprehensive Medication Management Services on Clinical Outcomes in Patients With Cardiovascular Diseases at Primary Care Level

Patients with established cardiovascular disease (CVD) often have multiple medications that increase the risk of prevalence of drug therapy problems (DTP), subsequently leading to unfavourable clinical and health outcomes. By providing Comprehensive Medication Management (CMM) services to patients within a healthcare system, pharmacists assess patients' medication-related needs, identify and prevent DTP, develop individualized care plan for each individual patient and evaluate and monitor outcomes. Thus, the CMM services delivered at the primary care level in collaboration with general practitioners and other healthcare providers could address this problem and by optimizing therapy improve patients' clinical outcomes and quality of life. Studies have shown that patients with chronic diseases have the greatest benefit from the CMM services. The aim of this study is to evaluate the impact of CMM services on clinical and humanistic outcomes in patients with established CVD. The study will employ prospective, longitudinal, pre- and postintervention study with a 1-year patient follow-up.

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Key information

Conditions

Cardiovascular Diseases in Old Age Cardiovascular Diseases

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Care Centre Zagreb - Centre, Zagreb, Croatia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hypertension
  • Established cardiovascular disease

Exclusion criteria

  • Organic, including symptomatic, mental disorders
  • Mental and behavioural disorders due to psychoactive substance use
  • Schizophrenia, schizotypal and delusional disorders
  • Behavioural syndromes associated with physiological disturbances and physical factors
  • Disorders of adult personality and behaviour
  • Mental retardation
  • Disorders of psychological development

Treatment and study plan

Comprehensive Medication Management services

Other

Comprehensive Medication Management services (CMM services) is an evidence-based and patient-centred service which involves an assessment of patient's medications to determine that each medication is appropriate, effective for the medical condition being treated, safe for the patient in the presence of other medications and co-morbidities, and that the patient is able and willing to take the medications as intended. As all patient care providers need a structured, rational thought process for sound clinical decision retrieval, the Pharmacotherapy Workup was developed and adopted as a systematic problem-solving process. This process represents the cognitive work taking place in the mind of the practitioner, and is used to identify, resolve, and prevent drug therapy problems (DTP), establish therapy goals, select interventions and evaluate outcomes.

Primary outcomes

  1. The impact of CMM services on blood pressure in elderly patients with established CVD

    Time frame: 1 year

    Within- and between-treatment differences for the intervention and the control group in blood pressure.

Secondary outcomes

  1. The impact of CMM services on LDL cholesterol, triglycerides, HDL cholesterol and total cholesterol in elderly patients with established CVD

    Time frame: 1 year

    Within- and between-treatment differences for the intervention and the control group in LDL cholesterol (mmol/L), triglycerides (mmol/L), HDL cholesterol (mmol/L) and total cholesterol (mmol/L).

  2. The impact of CMM services on health care utilization in elderly patients with established CVD

    Time frame: 1 year

    Between-treatment difference in the number of hospital admissions, emergency department visits and unplanned GPs visits.

  3. The impact of CMM services on drug therapy problems in elderly patients with established CVD

    Time frame: 1 year

    Number and type of drug therapy problems in the intervention group.

  4. The impact of CMM services on health related quality of life in elderly patients with established CVD assessed by EQ-5D-5L instrument.

    Time frame: 1 year

    Change from baseline in health related quality of life assessed by EQ-5D-5L instrument in the intervention group.

  5. The impact of CMM services on glycated haemoglobin in elderly patients with established CVD

    Time frame: 1 year

    Within- and between-treatment differences for the intervention and the control group in glycated haemoglobin.

Sponsors and collaborators

Lead sponsor

University of Zagreb

Other

Collaborators

  • Health Centre Zagreb - Centre (Dom zdravlja Zagreb - Centar)

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 3, 2021
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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